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Objective The primary objective of this trial was to evaluate the feasibility, safety, and efficacy of a predictive hyperglycemia and hypoglycemia minimization (PHHM) system vs predictive low glucose suspension (PLGS) alone in optimizing overnight glucose control in children 6 to 14 years old. Research Design and Methods Twenty‐eight participants 6 to 14 years old with T1D duration ≥1 year with daily insulin therapy ≥12 months and on insulin pump therapy for ≥6 months were randomized per night into PHHM mode or PLGS‐only mode for 42 nights. The primary outcome was percentage of time in sensor‐measured range 70 to 180 mg/dL in the overnight period. Results The addition of automated insulin delivery with PHHM increased time in target range (70‐180 mg/dL) from 66 ± 11% during PLGS nights to 76 ± 9% during PHHM nights (P<.001), without increasing hypoglycemia as measured by time below various thresholds. Average morning blood glucose improved from 176 ± 28 mg/dL following PLGS nights to 154 ± 19 mg/dL following PHHM nights (P<.001). Conclusions The PHHM system was effective in optimizing overnight glycemic control, significantly increasing time in range, lowering mean glucose, and decreasing glycemic variability compared to PLGS alone in children 6 to 14 years old.

To determine if intravitreal bevacizumab combined with the dexamethasone intravitreal implant 0.7 mg improves visual acuity and macular thickness more than bevacizumab monotherapy in eyes with macular edema due to branch and central retinal vein occlusions. Thirty eyes were randomly assigned to receive either combination therapy or bevacizumab monotherapy. All patients received intravitreal bevacizumab at baseline, followed by dexamethasone implants or sham injections 1 week later. Monthly bevacizumab injections were given if the central subfield thickness (CST) was >250 μm, and the combined group received a second implant at month 4 or 5 if CST was >250 μm. At 6 months, several secondary endpoints were met. Patients receiving combined therapy required fewer bevacizumab reinjections compared to those receiving monotherapy (two versus three; P=0.02), experienced greater mean reductions in CST from randomization (-56 μm versus +45 μm; P=0.01), and were more likely to have resolved all edema (CST <250 μm) (7/11 versus 2/14; P=0.02). The primary endpoint was not met since mean visual acuity changes from baseline were similar in the two groups (P=0.75). In patients with macular edema due to vein occlusions, bevacizumab with dexamethasone implants produces greater improvements in macular thickness compared to bevacizumab monotherapy, despite fewer bevacizumab injections.

Closed-loop systems that automate insulin delivery may improve glycemic outcomes in patients with type 1 diabetes. In this 6-month randomized, multicenter trial involving such patients, a closed-loop system led to a greater percentage of time with the glucose level in a target range than did a sensor-augmented insulin pump.

Importance As the number of patients with diabetes continues to increase in the United States, novel approaches to clinical care access should be considered to meet the care needs for this population, including support for diabetes-related technology. Objective To evaluate a virtual clinic to facilitate comprehensive diabetes care, support continuous glucose monitoring (CGM) integration into diabetes self-management, and provide behavioral health support for diabetes-related issues. Design, Setting, and Participants This cohort study was a prospective, single-arm, remote study involving adult participants with type 1 or type 2 diabetes who were referred through community resources. The study was conducted virtually from August 24, 2020, to May 26, 2022; analysis was conducted at the clinical coordinating center. Intervention Training and education led by a Certified Diabetes Care and Education Specialist for CGM use through a virtual endocrinology clinic structure, which included endocrinologists and behavioral health team members. Main Outcomes and Measures Main outcomes included CGM-measured mean glucose level, coefficient of variation, and time in range (TIR) of 70 to 180 mg/dL, time with values greater than 180 mg/dL or 250 mg/dL, and time with values less than 70 mg/dL or 54 mg/dL. Hemoglobin A1cwas measured at baseline and at 12 and 24 weeks. Results Among the 234 participants, 160 had type 1 diabetes and 74 had type 2 diabetes. The mean (SD) age was 47 (14) years, 123 (53%) were female, and median diabetes duration was 20 years. Median (IQR) CGM use over 6 months was 96% (91%-98%) for participants with type 1 diabetes and 94% (85%-97%) for those with type 2 diabetes. Mean (SD) hemoglobin A1c(HbA1c) in those with type 1 diabetes decreased from 7.8% (1.6%) at baseline to 7.1% (1.0%) at 3 months and 7.1% (1.0%) at 6 months (mean change from baseline to 6 months, −0.6%, 95% CI, −0.8% to −0.5%;P < .001), with an 11% mean TIR increase over 6 months (95% CI, 9% to 14%;P < .001). Mean HbA1cin participants with type 2 diabetes decreased from 8.1% (1.7%) at baseline to 7.1% (1.0%) at 3 months and 7.1% (0.9%) at 6 months (mean change from baseline to 6 months, −1.0%; 95% CI, −1.4% to −0.7%;P < .001), with an 18% TIR increase over 6 months (95% CI, 13% to 24%;P < .001). In participants with type 1 diabetes, mean percentage of time with values less than 70 mg/dL and less than 54 mg/dL decreased over 6 months by 0.8% (95% CI, −1.2% to −0.4%;P = .001) and by 0.3% (95% CI, −0.5% to −0.2%,P < .001), respectively. In the type 2 diabetes group, hypoglycemia was rare (mean [SD] percentage of time <70 mg/dL, 0.5% [0.6%]; and <54 mg/dL, 0.07% [0.14%], over 6 months). Conclusions and Relevance Results from this cohort study demonstrated clinical benefits associated with implementation of a comprehensive care model that included diabetes education. This model of care has potential to reach a large portion of patients with diabetes, facilitate diabetes technology adoption, and improve glucose control.

Objective To compare the frequency of elevated morning blood ketone levels according to age in 4–14 year olds with type 1 diabetes following overnight use of an automated low glucose insulin suspension system, or following control nights when the system was not used. Research design and methods For 28 children ages 4–9 years and 54 youth ages 10–14 years, elevation of morning blood ketone levels was assessed using the Precision Xtra Ketone meter following 1155 and 2345 nights, respectively. Repeated measures logistic regression models were used to compare age groups for blood ketone level elevation following control nights (system not activated) and following intervention nights with and without insulin suspension. Results Elevated morning blood ketones (≥0.6 mmol/L) were present following 10% of 580 control nights in the 4–9 year olds compared with 2% of 1162 control nights in 10–14 year olds (P < 0.001). Likewise, the frequency was greater following intervention nights in the younger age group (13% of 575 nights vs 2% of 1183 nights, P < 0.001). A longer duration of pump suspension resulted in a higher percentage of mornings with elevated blood ketones in the younger age group (P = 0.002), but not in the older age group (P = 0.63). The presence of elevated morning ketone levels did not progress to ketoacidosis in any subject. Conclusions Elevated morning blood ketones are more common in younger children with type 1 diabetes with or without nocturnal insulin suspension. Care providers need to be aware of the differences in ketogenesis in younger age children relative to various clinical situations.